Consumers are being advised not to purchase or use Rock Hard Extreme and Passion Coffee -- products promoted and sold as dietary supplements for sexual enhancement.
These products are promoted and sold on various Websites and possibly in some retail stores.
Users in jeopardy
Food and Drug Administration (FDA) laboratory analysis confirmed that Rock Hard Extreme and Passion Coffee contain the undeclared ingredient sulfaildenafil. Sulfaildenafil is structurally similar to sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for Erectile Dysfunction (ED).
The undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.
Do not use
Consumers should stop using these products immediately and throw them away. Anyone who has experienced any negative side effects is advised to consult a health care professional as soon as possible.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online, download the form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.
Expanding marketplace
FDA says there is a growing trend of products marketed as dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and bodybuilding, and are often represented as being “all natural.”
The agency is unable to test and identify all products marketed as dietary supplements on the market that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.
